Drug delivery device

ABSTRACT

A drug delivery device for administering a drug is presented having a body adapted to retain a cartridge containing a drug, at least one electrical unit and a port for electrically contacting the electrical unit, an adapter for attaching an injection needle to the drug delivery device, a safety mechanism arranged to prevent contacting the electrical unit through the port whilst an injection needle is in fluid communication with the cartridge and arranged to prevent establishing a fluid communication between an injection needle and the cartridge whilst the port is configured to allow contacting the electrical unit.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a U.S. National Phase Application pursuant to35 U.S.C. §371 of International Application No. PCT/EP2014/051469 filedJan. 27, 2014, which claims priority to European Patent Application No.13153136.0 filed Jan. 29, 2013. The entire disclosure contents of theseapplications are herewith incorporated by reference into the presentapplication.

TECHNICAL FIELD

The invention relates to a drug delivery device.

BACKGROUND

Administering an injection is a process which presents a number of risksand challenges for users and healthcare professionals, both mental andphysical.

Injection devices (i.e. devices capable of delivering medicaments from amedication container) typically fall into two categories—manual devicesand auto-injectors.

In a manual device—the user must provide the mechanical energy to drivethe fluid through the needle. This is typically done by some form ofbutton/plunger that has to be continuously pressed by the user duringthe injection. There are numerous disadvantages to the user from thisapproach. If the user stops pressing the button/plunger then theinjection will also stop. This means that the user can deliver anunderdose if the device is not used properly (i.e. the plunger is notfully pressed to its end position). Injection forces may be too high forthe user, in particular if the patient is elderly or has dexterityproblems.

The extension of the button/plunger may be too great. Thus it can beinconvenient for the user to reach a fully extended button. Thecombination of injection force and button extension can causetrembling/shaking of the hand which in turn increases discomfort as theinserted needle moves.

Auto-injector devices aim to make self-administration of injectedtherapies easier for patients. Current therapies delivered by means ofself-administered injections include drugs for diabetes (both insulinand newer GLP-1 class drugs), migraine, hormone therapies,anticoagulants etc.

Auto-injectors are devices which completely or partially replaceactivities involved in parenteral drug delivery from standard syringes.These activities may include removal of a protective syringe cap,insertion of a needle into a patient's skin, injection of themedicament, removal of the needle, shielding of the needle andpreventing reuse of the device. This overcomes many of the disadvantagesof manual devices. Injection forces/button extension, hand-shaking andthe likelihood of delivering an incomplete dose are reduced. Triggeringmay be performed by numerous means, for example a trigger button or theaction of the needle reaching its injection depth. In some devices theenergy to deliver the fluid is provided by a spring. In other devicesthis is achieved by an electromechanical drive. Devices withelectromechanical and/or electronic components may comprise a port whichmay serve for wired communication with another device for data transferor for charging.

SUMMARY

It is an object of the present invention to provide an improved drugdelivery device.

The object is achieved by a drug delivery device according to claim 1.

Preferred embodiments of the invention are given in the dependentclaims.

According to the invention a drug delivery device for administering adrug, comprises:

-   -   a body adapted to retain a cartridge containing a drug,    -   at least one electrical unit and a port for electrically        contacting the electrical unit,    -   an adapter for attaching an injection needle to the drug        delivery device,    -   a safety mechanism arranged to prevent contacting the electrical        unit through the port whilst an injection needle is in fluid        communication with the cartridge and arranged to prevent        establishing a fluid communication between an injection needle        and the cartridge whilst the port is configured to allow        contacting the electrical unit.

The port, e.g. a USB port, may serve for wired communication withanother device for data transfer or charging. The safety mechanismavoids the risk that the user may inadvertently leave the drug deliverydevice connected via a cable whilst attempting to inject. In this casethere may exist a potential conductive path from the externallyconnected device, through the cable, the port and the electronics of thedrug delivery device to the patient via the conductive metal injectionneedle. In case of a current overload on the port or a leaking cartridgewhich creates a short-circuit within the drug delivery device, thepatient would be subjected to an electric shock. An electric shock mayoccur either if both the patient and the external device connected tothe port are grounded or if the patient touches the port whilst theywere injecting regardless of whether a cable is connected to the port ornot. Similarly, the port may be adapted to interface with a bloodglucose strip for measuring a user's blood glucose value. The port willthus also feature electronic contacts. Consequently there is a similarassociated risk. The safety mechanism according to the inventionprevents this risk.

The above risk is addressed by providing a safety mechanism arranged toprevent access to the port whilst an injection needle is in fluidcommunication with the cartridge and arranged to prevent establishing afluid communication between an injection needle and the cartridge whilstthe port is accessible.

Other options would be to have the safety mechanism disable the dosingoperation of the drug delivery device when the user can access the port.This may be achieved by performing an operation which disables adelivery mechanism of the drug delivery device or by preventing the userfrom accessing a button or soft button on a human-machine interface foroperating the drug delivery device.

In an exemplary embodiment the adapter comprises a threaded area formounting a threaded needle. Instead of the threaded area the adapter maycomprise other means for attaching the needle such as a bayonet fit, acone or a Luer-lock.

The port may be arranged within the body behind an opening in the body.

In an exemplary embodiment a movable cover is arranged for exposing theopening in an open position or obscuring the opening in a closedposition.

The cover may be slidably and/or rotatably arranged with respect to thebody.

A spring may be arranged for biasing the cover towards the openposition.

In another exemplary embodiment a handle may be arranged on the coverfor facilitating operation.

In an exemplary embodiment a distal end of the cover protrudes into therange of the adapter in such a manner that the distal end interfereswith a needle hub of the needle being assembled to the adapter such thatthe needle hub displaces the distal end and the cover towards the closedposition thus ensuring that the cover cannot expose the port when aneedle is assembled to the adapter.

In an exemplary embodiment the cover comprises a sleeve shaped distalend, which in the open position protrudes in the distal direction tosuch an extent that an attached needle is hidden within the sleeveshaped distal end preventing its insertion into an injection site,wherein in the closed position the sleeve shaped distal end is retractedto at least partially expose the needle.

In an exemplary embodiment the cover is arranged as part of a needlecollar telescoped with the body, wherein when the needle is assembled tothe needle collar and the needle cover is in the open position, aproximal tip of the needle is spaced from a septum of the cartridge,wherein the proximal tip of the needle pierces the septum when theneedle collar with the assembled needle is moved into the closedposition. Although this embodiment allows for mounting a needle whilethe port is accessible the needle cannot establish a fluid communicationthus mitigating the aforesaid risks.

In an exemplary embodiment the needle collar has a thread interface withthe body such that the needle collar has to be rotated in order to movebetween the open and the closed position. If the adapter also comprisesa thread for assembling a threaded needle the user just screws theneedle onto the adapter and keeps on rotating thereby displacing theneedle collar towards the closed position while the needle pierces theseptum.

In an exemplary embodiment a pitch of the thread interface between theneedle collar and the body is greater than or equal to a length of theport or the opening in a longitudinal direction to ensure less than onerevolution of the needle collar around the body will result in an axialtravel equal to the length of the port.

In an exemplary embodiment the port is housed within an opening in theadapter such that when a needle is attached to the adapter a needle hubof the needle covers the opening and thus the port. This embodiment isparticularly simple and cost-efficient as it avoids further movablepart.

In an exemplary embodiment the port is arranged on a communication portsubassembly comprising a port hub attachable to the adapter, wherein theport hub comprises at least two electrical contacts connected to thecommunication port and arranged to contact a respective number ofelectrical contacts on or adjacent the adapter when the communicationport subassembly is attached to the adapter.

Further scope of applicability of the present invention will becomeapparent from the detailed description given hereinafter. However, itshould be understood that the detailed description and specificexamples, while indicating preferred embodiments of the invention, aregiven by way of illustration only, since various changes andmodifications within the spirit and scope of the invention will becomeapparent to those skilled in the art from this detailed description.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will become more fully understood from thedetailed description given hereinbelow and the accompanying drawingswhich are given by way of illustration only, and thus, are not limitiveof the present invention, and wherein:

FIG. 1 is a schematic longitudinal section of a first exemplaryembodiment of an electromechanical drug delivery device foradministering a drug comprising a port and a sliding cover in an openposition,

FIG. 2 is a schematic longitudinal detail section of the a firstembodiment of the electromechanical drug delivery device, wherein thesliding cover is in a closed position,

FIG. 3 is a longitudinal section of a second exemplary embodiment of thedrug delivery device with a sleeve shaped needle guard,

FIG. 4 is a longitudinal section of a third exemplary embodiment of thedrug delivery device with a needle collar in an open position,

FIG. 5 is a longitudinal section of the third embodiment of the drugdelivery device with the needle collar in the open position and a needleattached to the needle collar,

FIG. 6 is a longitudinal section of the third embodiment of the drugdelivery device with the needle collar in a closed position and theneedle attached to the needle collar,

FIG. 7 is a longitudinal section of a fourth exemplary embodiment of thedrug delivery device with the port housed in an opening within anadapter for mounting a needle,

FIG. 8 is a longitudinal section of a fourth exemplary embodiment of thedrug delivery device, wherein the port is arranged on a communicationport subassembly which may be mounted to the adapter,

FIG. 9 is a schematic longitudinal section of a sixth exemplaryembodiment of the electromechanical drug delivery device comprising aport and a rotatable cover in a closed position,

FIG. 10 is a schematic longitudinal section of the sixth embodiment ofthe electromechanical drug delivery device with the cover in an openposition, and

FIG. 11 is a schematic longitudinal section of the sixth embodiment ofthe electromechanical drug delivery device with a needle attacheddisplacing the cover into the closed position.

Corresponding parts are marked with the same reference symbols in allfigures.

DETAILED DESCRIPTION

FIG. 1 is a schematic longitudinal section of a first exemplaryembodiment of an electromechanical drug delivery device 1 foradministering a drug. The drug delivery device 1 comprises a body 2adapted to receive a drug cartridge 3 or syringe. A hypodermic needle 4may be attached to the cartridge 3, preferably a needle 4 with two tips,one of them for piercing an injection site and the other for piercing aseptum 11 on the cartridge 3 for establishing a fluid communicationbetween the cartridge 3 and the needle 4. The drug delivery device 1further comprises at least one electric unit EU or electronic devicesuch as a control unit and/or a human-machine-interface forcommunicating information to a user and for allowing the user to operatethe drug delivery device and/or an electromechanical drive (notillustrated) for inserting the needle 4 into an injection site, e.g. apatient's skin and/or dispensing drug from the cartridge 3 through theneedle 4 and/or retracting the needle 4 post-injection.

The body 2 comprises an adapter 7 for attaching the needle 4. Theadapter 7 may be arranged as a threaded area 7. The needle 4 may beattached and removed by the user thus allowing it to be used for asingle delivery of the drug. After delivery the needle 4 is removed,discarded and replaced by a new one, if applicable.

The drug delivery device 1 comprises a port 6 which may serve for wiredcommunication with another device for data transfer or charging. Thereis an associated risk with this feature that the user may inadvertentlyleave the drug delivery device 1 connected via a cable whilst attemptingto inject. Whilst a control unit of the drug delivery device 1 may runsoftware including checks to prevent the delivery of the drug in thissituation, there will still exist a potential conductive path from theexternally connected device, through the cable, the port 6 and theelectronics of the drug delivery device 1 to the patient via theconductive metal needle 4. It is thus possible that, for instance, acurrent overload on the port 6 or a leaking cartridge 3 which creates ashort-circuit within the drug delivery device 1, could deliver anelectric shock to the patient. This may occur either if both the patientand the external device connected to the port 6 are grounded or if thepatient touches the port 6 whilst they were injecting regardless ofwhether a cable is connected to the port 6 or not.

Similarly, the port 6 may be adapted to interface with a blood glucosestrip for measuring a user's blood glucose value. The port 6 will thusalso feature electronic contacts. Consequently there is a similarassociated risk.

The above risk is addressed by providing a safety mechanism to disablethe dosing operation of the drug delivery device 1 when the user canaccess the port 6. This is achieved by performing an operation whichdisables a delivery mechanism of the drug delivery device 1 or bypreventing the user from accessing an adapter 7 such as a threaded area7 of the drug delivery device 1 adapted to connect to the needle 4 orfrom accessing a button or soft button on the human-machine interface.

In the embodiment of FIG. 1 the port is housed within an opening 14within the body 2. The adapter 7 or threaded area 7 of the drug deliverydevice 1 is arranged on the body 2. The safety mechanism 51 comprises asliding cover 8 arranged slidably relative to the body 2 between adistal open position OP as illustrated in FIG. 1 and a proximal closedposition CP as illustrated in FIG. 2, where the cover 8 obscures theopening 14 and the port 6. A spring 9 is arranged to bias the cover 8towards the distal open position OP, in which the cover 8 is removedfrom the opening 14 so as to expose the port 6. A distal end 10 of thecover 8 protrudes through the body 2 in a distal direction D into therange of the adapter 7 in such a manner that the distal end 10interferes with a needle hub 4.1 of the needle 4 during assembly of theneedle 4. If a needle 4 is assembled, e.g. screwed onto the adapter 7,the needle hub 4.1 displaces the distal end 10 and thus the cover 8towards the proximal closed position CP against the bias of the spring 9as illustrated in FIG. 2, such that the port 6 is inaccessible when aneedle 4 is attached. When no needle 4 is present the spring 9 isallowed to relax and move the cover 8 towards the distal open positionOP thus exposing the port 6 and allowing access.

FIG. 3 is a longitudinal section of a second exemplary embodiment of thedrug delivery device 1.

The drug delivery device 1 comprises a body 2 adapted to receive a drugcartridge 3 or syringe. A hypodermic needle 4 may be attached to thecartridge 3, preferably a needle 4 with two tips, one of them forpiercing an injection site and the other for piercing a septum 11 on thecartridge 3 for establishing a fluid communication between the cartridge3 and the needle 4. The drug delivery device 1 further comprises atleast one electrical unit EU such as a control unit and/or ahuman-machine-interface for communicating information to a user and forallowing the user to operate the drug delivery device and/or anelectromechanical drive (not illustrated) for inserting the needle 4into an injection site, e.g. a patient's skin and/or dispensing drugfrom the cartridge 3 through the needle 4 and/or retracting the needle 4post-injection.

The body 2 comprises an adapter 7 for attaching the needle 4. Theadapter 7 may be arranged as a threaded area 7. The needle 4 may beattached and removed by the user thus allowing it to be used for asingle delivery of the drug. After delivery the needle 4 is removed,discarded and replaced by a new one, if applicable.

The drug delivery device 1 comprises a port 6 which may serve for wiredcommunication with another device for data transfer or charging.

In the embodiment of FIG. 3 the port is housed within an opening 14within the body 2. The adapter 7 or threaded area 7 of the drug deliverydevice 1 is arranged on the body 2. The safety mechanism S2 comprises asliding cover 8 arranged slidably relative to the body 2 between adistal open position OP as illustrated in FIG. 3 and a proximal closedposition CP (not illustrated), where the cover 8 obscures the opening 14and the port 6. A spring (not illustrated) may be arranged to bias thecover 8 towards the distal open position OP, in which the cover 8 isremoved from the opening 14 so as to expose the port 6. A distal end 10of the cover 8 protrudes through the body 2 in a distal direction D andtakes the shape of a sleeve needle guard. As the sliding cover 8 is inthe distal open position OP the needle guard 10 protrudes in the distaldirection D to such an extent that the needle 4 is hidden within needleguard 10 and cannot be inserted into an injection site such as apatient's skin. If the needle guard 10 is moved in a proximal directionP the cover 8 is moved towards its proximal closed position CP obscuringthe port 6 while the needle 4 is exposed for allowing insertion into aninjection site. Other than in the embodiment of FIGS. 1 and 2 the port 6may be accessible when a needle 4 is attached. However, as the port 6 isaccessible the needle 4 cannot be inserted thus also mitigating theabove described risk.

FIG. 4 is a longitudinal section of a third exemplary embodiment of thedrug delivery device 1.

The drug delivery device 1 comprises a body 2 adapted to receive a drugcartridge 3 or syringe. A hypodermic needle 4 (cf. FIG. 5) may beattached to the cartridge 3, preferably a needle 4 with two tips, one ofthem for piercing an injection site and the other for piercing a septum11 on the cartridge 3 for establishing a fluid communication between thecartridge 3 and the needle 4. The drug delivery device 1 furthercomprises at least one electrical unit EU such as a control unit and/ora human-machine-interface for communicating information to a user andfor allowing the user to operate the drug delivery device and/or anelectromechanical drive (not illustrated) for inserting the needle 4into an injection site, e.g. a patient's skin and/or dispensing drugfrom the cartridge 3 through the needle 4 and/or retracting the needle 4post-injection.

The drug delivery device 1 comprises an adapter 7 for attaching theneedle 4. The adapter 7 may be arranged as a threaded area 7. The needle4 may be attached and removed by the user thus allowing it to be usedfor a single delivery of the drug. After delivery the needle 4 isremoved, discarded and replaced by a new one, if applicable.

The drug delivery device 1 comprises a port 6 which may serve for wiredcommunication with another device for data transfer or charging.

In the embodiment of FIG. 4 the port is housed within an opening 14 inthe body 2. The safety mechanism S3 comprises a cover 8 arranged as partof a needle collar 12 telescoped with the body 2.

The needle collar 12 has a thread interface 13 with the body 2 whosepitch may be greater than or equal to a length of the port 6 or theopening 14 in a longitudinal direction D, P; to ensure less than onerevolution of the needle collar around the body 2 will result in anaxial travel equal to the length of the port. The adapter 7 is alsoarranged on the needle collar 12 to allow the needle 4 to assemble tothe drug delivery device 1. The adapter 7 is preferably threaded toallow assembly of a threaded needle 4.

When a needle 4 is not assembled to the drug delivery device 1 theneedle collar 12 is in its distal open position OP, shown in FIG. 4. Inthis state the port 6, located in the opening 14 in the body 2, isaccessible to the user.

The needle 4 assembles to the needle collar 12 using the threadinterface of the adapter 7. When the needle 4 is fully assembled to theneedle collar 12, the port 6 is still accessible to the user; howeverthe proximal tip of the needle 4 has not yet pierced the septum 11. FIG.5 is a longitudinal section of the third exemplary embodiment of thedrug delivery device 1 with the needle 4 assembled to the adapter 7 onthe needle collar 12.

After the needle 4 is fully assembled to the needle collar 12, the usercontinues to apply torque to the needle 4. This forces the needle 4 andthe needle collar 12 to take the helical path provided by the threadinterface 13 between the needle collar and the body 2. The needle 4 thusmoves towards the cartridge 3 and the proximal tip of the needle 4pierces the septum while the needle collar 12 moves over the opening 14thus obscuring the port 6. FIG. 6 is a longitudinal section of the thirdexemplary embodiment of the drug delivery device 1 with the needle 4assembled to the adapter 7 on the needle collar 12 and the needle collar12 obscuring the port 6.

FIG. 7 is a longitudinal section of a fourth exemplary embodiment of thedrug delivery device 1.

The drug delivery device 1 comprises a body 2 adapted to receive a drugcartridge 3 or syringe. A hypodermic needle 4, not illustrated butsimilar to the needles 4 in the previously described embodiments, may beattached to the cartridge 3, preferably a needle 4 with two tips, one ofthem for piercing an injection site and the other for piercing a septum11 on the cartridge 3 for establishing a fluid communication between thecartridge 3 and the needle 4. The drug delivery device 1 furthercomprises at least one electrical unit EU such as a control unit and/ora human-machine-interface for communicating information to a user andfor allowing the user to operate the drug delivery device and/or anelectromechanical drive (not illustrated) for inserting the needle 4into an injection site, e.g. a patient's skin and/or dispensing drugfrom the cartridge 3 through the needle 4 and/or retracting the needle 4post-injection.

The body 2 comprises an adapter 7 for attaching the needle 4. Theadapter 7 may be arranged as a threaded area 7. The needle 4 may beattached and removed by the user thus allowing it to be used for asingle delivery of the drug. After delivery the needle 4 is removed,discarded and replaced by a new one, if applicable.

The drug delivery device 1 comprises a port 6 which may serve for wiredcommunication with another device for data transfer or charging.

In the embodiment of FIG. 7 the safety mechanism S4 is provided byhousing the port 6 within an opening 14 in the adapter 7. The port 6 isaccessible if no needle 4 is attached to the adapter 7. When a needle 4is attached the needle hub 4.1 covers the opening 14 and thus the port6, making it non-accessible.

FIG. 8 is a longitudinal section of a fifth exemplary embodiment of thedrug delivery device 1.

The drug delivery device 1 comprises a body 2 adapted to receive a drugcartridge 3 or syringe. A hypodermic needle 4 may be attached to thecartridge 3, preferably a needle 4 with two tips, one of them forpiercing an injection site and the other for piercing a septum 11 on thecartridge 3 for establishing a fluid communication between the cartridge3 and the needle 4. The drug delivery device 1 further comprises atleast one electrical unit EU such as a control unit and/or ahuman-machine-interface for communicating information to a user and forallowing the user to operate the drug delivery device and/or anelectromechanical drive (not illustrated) for inserting the needle 4into an injection site, e.g. a patient's skin and/or dispensing drugfrom the cartridge 3 through the needle 4 and/or retracting the needle 4post-injection.

The body 2 comprises an adapter 7 for attaching the needle 4. Theadapter 7 may be arranged as or comprise a threaded area 7. The needle 4may be attached and removed by the user thus allowing it to be used fora single delivery of the drug. After delivery the needle 4 is removed,discarded and replaced by a new one, if applicable.

The drug delivery device 1 comprises a port 6 which may serve for wiredcommunication with another device for data transfer or charging. Thesafety mechanism S5 is provided by the port 6 being arranged on acommunication port subassembly 16 comprising a port hub 16.1 similar tothe needle hub 4.1. The port hub 16.1 comprises a thread interfacesimilar to the one of the needle hub 4.1 such that either the needle 4or the communication port subassembly 16 may be attached to the adapter7. Furthermore the port hub 16.1 comprises at least two electricalcontacts 15 connected to the communication port 6 and arranged tocontact a respective number of electrical contacts on or adjacent theadapter 7 when the communication port subassembly 16 is completelyscrewed onto the adapter 7.

The port 6 can therefore only be attached to the drug delivery device ifno needle 4 is present. On the other hand, attaching a needle 4 requiresthat the communication port subassembly 16 is not attached.

FIG. 9 is a schematic longitudinal section of a sixth exemplaryembodiment of an electromechanical drug delivery device 1 foradministering a drug. The drug delivery device 1 comprises a body 2adapted to receive a drug cartridge 3 or syringe. A hypodermic needle 4may be attached to the cartridge 3, preferably a needle 4 with two tips,one of them for piercing an injection site and the other for piercing aseptum 11 on the cartridge 3 for establishing a fluid communicationbetween the cartridge 3 and the needle 4. The drug delivery device 1further comprises at least one electrical unit EU such as a control unitand/or a human-machine-interface for communicating information to a userand for allowing the user to operate the drug delivery device and/or anelectromechanical drive (not illustrated) for inserting the needle 4into an injection site, e.g. a patient's skin and/or dispensing drugfrom the cartridge 3 through the needle 4 and/or retracting the needle 4post-injection.

The body 2 comprises an adapter 7 for attaching the needle 4. Theadapter 7 may be arranged as a threaded area 7. The needle 4 may beattached and removed by the user thus allowing it to be used for asingle delivery of the drug. After delivery the needle 4 is removed,discarded and replaced by a new one, if applicable.

The drug delivery device 1 comprises a port 6 which may serve for wiredcommunication with another device for data transfer or charging.

In the embodiment of FIG. 9 the port is housed within an opening 14within the body 2. The adapter 7 or threaded area 7 of the drug deliverydevice 1 is arranged on the body 2. The safety mechanism S6 comprises afolding cover 8 pivoted on the body 2 between a closed position CP asillustrated in FIG. 9 and an open position OP as illustrated in FIG. 10,where the cover 8 exposes the opening 14 and the port 6. A spring (notillustrated) may be arranged to bias the cover 8 towards the openposition OP, in which the cover 8 is removed from the opening 14 so asto expose the port 6. An engagement surface 8.1 such as a pin of thecover 8 is arranged adjacent the adapter 7 in such a manner that itinterferes with a needle hub 4.1 of the needle 4 during assembly of theneedle 4. If a needle 4 is assembled, e.g. screwed onto the adapter 7,the needle hub 4.1 displaces the engagement surface 8.1 and thus thecover 8 towards the closed position CP as illustrated in FIG. 11, suchthat the port 6 is inaccessible when a needle 4 is attached. When noneedle 4 is present as in FIG. 10 the cover 8 may be rotated to the openposition OP, e.g. by means of a handle 8.2 on the cover 8 or biased by aspring, thus exposing the port 6 and allowing access. Hence, as long asthe needle 4 is attached, the cover 8 cannot be moved to the openposition OP.

Instead of the threaded area 7 the adapter 7 may comprise other meansfor attaching the needle 4 such as a bayonet fit, a cone or a Luer-lock.

The safety mechanism may in general comprise either purely mechanicalmeans or an electronically actuated mechanical system. The safetymechanism could potentially make use of physical detents or magneticelements to assist in the latching of the parts into the open or closedpositions.

The term “drug” or “medicament”, as used herein, means a pharmaceuticalformulation containing at least one pharmaceutically active compound,

wherein in one embodiment the pharmaceutically active compound has amolecular weight up to 1500 Da and/or is a peptide, a proteine, apolysaccharide, a vaccine, a DNA, a RNA, an enzyme, an antibody or afragment thereof, a hormone or an oligonucleotide, or a mixture of theabove-mentioned pharmaceutically active compound,

wherein in a further embodiment the pharmaceutically active compound isuseful for the treatment and/or prophylaxis of diabetes mellitus orcomplications associated with diabetes mellitus such as diabeticretinopathy, thromboembolism disorders such as deep vein or pulmonarythromboembolism, acute coronary syndrome (ACS), angina, myocardialinfarction, cancer, macular degeneration, inflammation, hay fever,atherosclerosis and/or rheumatoid arthritis,

wherein in a further embodiment the pharmaceutically active compoundcomprises at least one peptide for the treatment and/or prophylaxis ofdiabetes mellitus or complications associated with diabetes mellitussuch as diabetic retinopathy,

wherein in a further embodiment the pharmaceutically active compoundcomprises at least one human insulin or a human insulin analogue orderivative, glucagon-like peptide (GLP-1) or an analogue or derivativethereof, or exendin-3 or exendin-4 or an analogue or derivative ofexendin-3 or exendin-4.

Insulin analogues are for example Gly(A21), Arg(B31), Arg(B32) humaninsulin; Lys(B3), Glu(B29) human insulin; Lys(B28), Pro(B29) humaninsulin; Asp(B28) human insulin; human insulin, wherein proline inposition B28 is replaced by Asp, Lys, Leu, Val or Ala and wherein inposition B29 Lys may be replaced by Pro; Ala(B26) human insulin;Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) humaninsulin.

Insulin derivates are for example B29-N-myristoyl-des(B30) humaninsulin; B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl humaninsulin; B29-N-palmitoyl human insulin; B28-N-myristoyl LysB28ProB29human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin;B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl-ThrB29LysB30human insulin; B29-N-(N-palmitoyl-Y-glutamyl)-des(B30) human insulin;B29-N-(N-lithocholyl-Y-glutamyl)-des(B30) human insulin;B29-N-(w-carboxyheptadecanoyl)-des(B30) human insulin andB29-N-(w-carboxyheptadecanoyl) human insulin.

Exendin-4 for example means Exendin-4(1-39), a peptide of the sequenceH-His-Gly-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln-Met-Glu-Glu-Glu-Ala-Val-Arg-Leu-Phe-Ile-Glu-Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH2.

Exendin-4 derivatives are for example selected from the following listof compounds:

-   H-(Lys)4-des Pro36, des Pro37 Exendin-4(1-39)-NH2,-   H-(Lys)5-des Pro36, des Pro37 Exendin-4(1-39)-NH2,-   des Pro36 Exendin-4(1-39),-   des Pro36 [Asp28] Exendin-4(1-39),-   des Pro36 [IsoAsp28] Exendin-4(1-39),-   des Pro36 [Met(O)14, Asp28] Exendin-4(1-39),-   des Pro36 [Met(O)14, IsoAsp28] Exendin-4(1-39),-   des Pro36 [Trp(O2)25, Asp28] Exendin-4(1-39),-   des Pro36 [Trp(O2)25, IsoAsp28] Exendin-4(1-39),-   des Pro36 [Met(O)14 Trp(O2)25, Asp28] Exendin-4(1-39),-   des Pro36 [Met(O)14 Trp(O2)25, IsoAsp28] Exendin-4(1-39); or-   des Pro36 [Asp28] Exendin-4(1-39),-   des Pro36 [IsoAsp28] Exendin-4(1-39),-   des Pro36 [Met(O)14, Asp28] Exendin-4(1-39),-   des Pro36 [Met(O)14, IsoAsp28] Exendin-4(1-39),

des Pro36 [Trp(O2)25, Asp28] Exendin-4(1-39),

-   des Pro36 [Trp(O2)25, IsoAsp28] Exendin-4(1-39),-   des Pro36 [Met(O)14 Trp(O2)25, Asp28] Exendin-4(1-39),-   des Pro36 [Met(O)14 Trp(O2)25, IsoAsp28] Exendin-4(1-39),    wherein the group -Lys6-NH2 may be bound to the C-terminus of the    Exendin-4 derivative;    or an Exendin-4 derivative of the sequence-   des Pro36 Exendin-4(1-39)-Lys6-NH2 (AVE0010),-   H-(Lys)6-des Pro36 [Asp28] Exendin-4(1-39)-Lys6-NH2,-   des Asp28 Pro36, Pro37, Pro38Exendin-4(1-39)-NH2,-   H-(Lys)6-des Pro36, Pro38 [Asp28] Exendin-4(1-39)-NH2,-   H-Asn-(Glu)5des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1-39)-NH2,-   des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1-39)-(Lys)6-NH2,-   H-(Lys)6-des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1-39)-(Lys)6-NH2,-   H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Asp28]    Exendin-4(1-39)-(Lys)6-NH2,-   H-(Lys)6-des Pro36 [Trp(O2)25, Asp28] Exendin-4(1-39)-Lys6-NH2,-   H-des Asp28 Pro36, Pro37, Pro38 [Trp(O2)25] Exendin-4(1-39)-NH2,-   H-(Lys)6-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28]    Exendin-4(1-39)-NH2,-   H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28]    Exendin-4(1-39)-NH2,-   des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28]    Exendin-4(1-39)-(Lys)6-NH2,-   H-(Lys)6-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28]    Exendin-4(1-39)-(Lys)6-NH2,-   H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28]    Exendin-4(1-39)-(Lys)6-NH2,-   H-(Lys)6-des Pro36 [Met(O)14, Asp28] Exendin-4(1-39)-Lys6-NH2,-   des Met(O)14 Asp28 Pro36, Pro37, Pro38 Exendin-4(1-39)-NH2,-   H-(Lys)6-desPro36, Pro37, Pro38 [Met(O)14, Asp28]    Exendin-4(1-39)-NH2,-   H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(O)14, Asp28]    Exendin-4(1-39)-NH2,-   des Pro36, Pro37, Pro38 [Met(O)14, Asp28]    Exendin-4(1-39)-(Lys)6-NH2,-   H-(Lys)6-des Pro36, Pro37, Pro38 [Met(O)14, Asp28]    Exendin-4(1-39)-(Lys)6-NH2,-   H-Asn-(Glu)5 des Pro36, Pro37, Pro38 [Met(O)14, Asp28]    Exendin-4(1-39)-(Lys)6-NH2,-   H-Lys6-des Pro36 [Met(O)14, Trp(O2)25, Asp28]    Exendin-4(1-39)-Lys6-NH2,-   H-des Asp28 Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25]    Exendin-4(1-39)-NH2,-   H-(Lys)6-des Pro36, Pro37, Pro38 [Met(O)14, Asp28]    Exendin-4(1-39)-NH2,-   H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25, Asp28]    Exendin-4(1-39)-NH2,-   des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25, Asp28]    Exendin-4(1-39)-(Lys)6-NH2,-   H-(Lys)6-des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25, Asp28]    Exendin-4(S1-39)-(Lys)6-NH2,-   H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25, Asp28]    Exendin-4(1-39)-(Lys)6-NH2;    or a pharmaceutically acceptable salt or solvate of any one of the    afore-mentioned Exendin-4 derivative.

Hormones are for example hypophysis hormones or hypothalamus hormones orregulatory active peptides and their antagonists as listed in RoteListe, ed. 2008, Chapter 50, such as Gonadotropine (Follitropin,Lutropin, Choriongonadotropin, Menotropin), Somatropine (Somatropin),Desmopressin, Terlipressin, Gonadorelin, Triptorelin, Leuprorelin,Buserelin, Nafarelin, Goserelin.

A polysaccharide is for example a glucosaminoglycane, a hyaluronic acid,a heparin, a low molecular weight heparin or an ultra low molecularweight heparin or a derivative thereof, or a sulphated, e.g. apoly-sulphated form of the above-mentioned polysaccharides, and/or apharmaceutically acceptable salt thereof. An example of apharmaceutically acceptable salt of a poly-sulphated low molecularweight heparin is enoxaparin sodium.

Antibodies are globular plasma proteins (˜150 kDa) that are also knownas immunoglobulins which share a basic structure. As they have sugarchains added to amino acid residues, they are glycoproteins. The basicfunctional unit of each antibody is an immunoglobulin (Ig) monomer(containing only one Ig unit); secreted antibodies can also be dimericwith two Ig units as with IgA, tetrameric with four Ig units liketeleost fish IgM, or pentameric with five Ig units, like mammalian IgM.

The Ig monomer is a “Y”-shaped molecule that consists of fourpolypeptide chains; two identical heavy chains and two identical lightchains connected by disulfide bonds between cysteine residues. Eachheavy chain is about 440 amino acids long; each light chain is about 220amino acids long. Heavy and light chains each contain intrachaindisulfide bonds which stabilize their folding. Each chain is composed ofstructural domains called Ig domains. These domains contain about 70-110amino acids and are classified into different categories (for example,variable or V, and constant or C) according to their size and function.They have a characteristic immunoglobulin fold in which two β sheetscreate a “sandwich” shape, held together by interactions betweenconserved cysteines and other charged amino acids.

There are five types of mammalian Ig heavy chain denoted by α, δ, ε, γ,and μ. The type of heavy chain present defines the isotype of antibody;these chains are found in IgA, IgD, IgE, IgG, and IgM antibodies,respectively.

Distinct heavy chains differ in size and composition; α and γ containapproximately 450 amino acids and 6 approximately 500 amino acids, whileμ and ε have approximately 550 amino acids. Each heavy chain has tworegions, the constant region (C_(H)) and the variable region (V_(H)). Inone species, the constant region is essentially identical in allantibodies of the same isotype, but differs in antibodies of differentisotypes. Heavy chains γ, α and δ have a constant region composed ofthree tandem Ig domains, and a hinge region for added flexibility; heavychains μ and ε have a constant region composed of four immunoglobulindomains. The variable region of the heavy chain differs in antibodiesproduced by different B cells, but is the same for all antibodiesproduced by a single B cell or B cell clone. The variable region of eachheavy chain is approximately 110 amino acids long and is composed of asingle Ig domain.

In mammals, there are two types of immunoglobulin light chain denoted byλ and κ. A light chain has two successive domains: one constant domain(CL) and one variable domain (VL). The approximate length of a lightchain is 211 to 217 amino acids. Each antibody contains two light chainsthat are always identical; only one type of light chain, κ or λ, ispresent per antibody in mammals.

Although the general structure of all antibodies is very similar, theunique property of a given antibody is determined by the variable (V)regions, as detailed above. More specifically, variable loops, threeeach the light (VL) and three on the heavy (VH) chain, are responsiblefor binding to the antigen, i.e. for its antigen specificity. Theseloops are referred to as the Complementarity Determining Regions (CDRs).Because CDRs from both VH and VL domains contribute to theantigen-binding site, it is the combination of the heavy and the lightchains, and not either alone, that determines the final antigenspecificity.

An “antibody fragment” contains at least one antigen binding fragment asdefined above, and exhibits essentially the same function andspecificity as the complete antibody of which the fragment is derivedfrom. Limited proteolytic digestion with papain cleaves the Ig prototypeinto three fragments. Two identical amino terminal fragments, eachcontaining one entire L chain and about half an H chain, are the antigenbinding fragments (Fab). The third fragment, similar in size butcontaining the carboxyl terminal half of both heavy chains with theirinterchain disulfide bond, is the crystalizable fragment (Fc). The Fccontains carbohydrates, complement-binding, and FcR-binding sites.Limited pepsin digestion yields a single F(ab′)2 fragment containingboth Fab pieces and the hinge region, including the H—H interchaindisulfide bond. F(ab′)2 is divalent for antigen binding. The disulfidebond of F(ab′)2 may be cleaved in order to obtain Fab′. Moreover, thevariable regions of the heavy and light chains can be fused together toform a single chain variable fragment (scFv).

Pharmaceutically acceptable salts are for example acid addition saltsand basic salts. Acid addition salts are e.g. HCl or HBr salts. Basicsalts are e.g. salts having a cation selected from alkali or alkaline,e.g. Na+, or K+, or Ca2+, or an ammonium ion N+(R1)(R2)(R3)(R4), whereinR1 to R4 independently of each other mean: hydrogen, an optionallysubstituted C1-C6-alkyl group, an optionally substituted C2-C6-alkenylgroup, an optionally substituted C6-C10-aryl group, or an optionallysubstituted C6-C10-heteroaryl group. Further examples ofpharmaceutically acceptable salts are described in “Remington'sPharmaceutical Sciences” 17. ed. Alfonso R. Gennaro (Ed.), MarkPublishing Company, Easton, Pa., U.S.A., 1985 and in Encyclopedia ofPharmaceutical Technology.

Pharmaceutically acceptable solvates are for example hydrates.

Those of skill in the art will understand that modifications (additionsand/or removals) of various components of the apparatuses, methodsand/or systems and embodiments described herein may be made withoutdeparting from the full scope and spirit of the present invention, whichencompass such modifications and any and all equivalents thereof.

1-15. (canceled)
 16. Drug delivery device for administering a drug,comprising: a body adapted to retain a cartridge containing a drug, atleast one electrical unit and a port for electrically contacting theelectrical unit, an adapter for attaching an injection needle to thedrug delivery device, a safety mechanism arranged to prevent contactingthe electrical unit through the port whilst an injection needle is influid communication with the cartridge and arranged to preventestablishing a fluid communication between an injection needle and thecartridge whilst the port is configured to allow contacting theelectrical unit.
 17. Drug delivery device according to claim 16, whereinthe adapter comprises a threaded area for mounting a threaded needle.18. Drug delivery device according to claim 16, wherein the port isarranged within the body behind an opening in the body.
 19. Drugdelivery device according to claim 18, wherein a movable cover isarranged for exposing the opening in an open position or obscuring theopening in a closed position.
 20. Drug delivery device according toclaim 19, wherein the cover is slidably arranged with respect to thebody.
 21. Drug delivery device according to claim 19, wherein the coveris rotatably arranged with respect to the body.
 22. Drug delivery deviceaccording to claim 19, wherein a spring is arranged for biasing thecover towards the open position.
 23. Drug delivery device according toclaim 19, wherein a handle is arranged on the cover.
 24. Drug deliverydevice according to claim 19, wherein a distal end of the coverprotrudes into the range of the adapter in such a manner that the distalend interferes with a needle hub of the needle being assembled to theadapter such that the needle hub displaces the distal end and the covertowards the closed position.
 25. Drug delivery device according to claim19, wherein the cover comprises a sleeve shaped distal end, which in theopen position protrudes in the distal direction to such an extent thatan attached needle is hidden within the sleeve shaped distal endpreventing its insertion into an injection site, wherein in the closedposition the sleeve shaped distal end is retracted to at least partiallyexpose the needle.
 26. Drug delivery device according to claim 19,wherein the cover is arranged as part of a needle collar telescoped withthe body, wherein when the needle is assembled to the needle collar andthe needle cover is in the open position, a proximal tip of the needleis spaced from a septum of the cartridge, wherein the proximal tip ofthe needle pierces the septum when the needle collar with the assembledneedle is moved into the closed position.
 27. Drug delivery deviceaccording to claim 26, wherein the needle collar has a thread interfacewith the body.
 28. Drug delivery device according to claim 27, wherein apitch of the thread interface is greater than or equal to a length ofthe port or the opening in a longitudinal direction.
 29. Drug deliverydevice according to claim 16, wherein the port is housed within anopening in the adapter such that when a needle is attached to theadapter a needle hub of the needle covers the opening and thus the port.30. Drug delivery device according to claim 16, wherein the port isarranged on a communication port subassembly comprising a port hubattachable to the adapter, wherein the port hub comprises at least twoelectrical contacts connected to the communication port and arranged tocontact a respective number of electrical contacts on or adjacent theadapter when the communication port subassembly is attached to theadapter.